Tamiflu Warning To Include Psychiatric Effects Could Be Due To Flu

The US Food and Drug Administration (FDA) Pediatric Advisory Committee recommended to the agency yesterday, Tuesday 27th November, that makers of the flu drug Tamiflu be urged to change the drug's warning label to include the fact that the psychiatric symptoms experienced by children on the drug could be caused by having the flu.

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According to a report in WebMD, the FDA panel's vote was 8 to 6, and reflected the agency's uncertainty about whether the drug or the condition led to nearly 600 reported psychiatric incidents worldwide, most of them in Japan, since the drug was introduced. The incidents, of which 20 per cent were in the US, included self-harming behaviour, delirium and suicide attempts. 25 of them were fatal, with 3 of the deaths being in the US.

The drug's warning label was changed last year following reports of psychiatric symptoms in patients taking the drug. But the panel is not asking for the warnings to be removed, only that information is added to explain that the symptoms could be caused by the flu itself.